Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OXY PANEL CLIA WAIVED DIP CARD OXY100
Instant Technologies, Inc.
ABTDOXW11401A
In Commercial Distribution

  • 30817405023784 ()
  • 00817405023783 ()
  • 10817405023780 ()
ABTDOXW11401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Morphine (MOP) Single Drug Urine Test Panel
Instant Technologies, Inc.
AWDMO-114
In Commercial Distribution

  • 00817405021093 ()
AWDMO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RFB FLAT PANEL LCD 19 NDS RADIANCE
Smith & Nephew, Inc.
72200020F
In Commercial Distribution

  • 03596010611598 ()
72200020F

  • Image display unit, colour
Alere Triage® Profiler SOB™ Panel
ALERE SAN DIEGO, INC.
97300EU
Not in Commercial Distribution

  • 00899722002740 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
HYDRATHERM FUSE KIT CONTROL PANEL REPAIR PART
COMPASS HEALTH BRANDS CORP.
HT-TU-FUSEKIT
In Commercial Distribution

  • 00092237625491 ()


  • Hot therapy pack heating unit
4 Panel OralTox - AMP/COC/OPI/PCP
PREMIER BIOTECH, INC
OT80404
Not in Commercial Distribution

  • B313OT804041 ()
  • B3130T804040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - COC/MET/OPI/OXY
PREMIER BIOTECH, INC
OT80402
Not in Commercial Distribution

  • B313OT804021 ()
  • B313OT804020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - AMP/COC/OPI/THC
PREMIER BIOTECH, INC
OT80401
Not in Commercial Distribution

  • B313OT804011 ()
  • B313OT804010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MTD-OPI300-OXY-PPX-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61093-2
Not in Commercial Distribution

  • B2986109320 ()
61093-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61056-2
Not in Commercial Distribution

  • B2986105620 ()
61056-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC-pH,SG.OX
Express Diagnostic Int'l, Inc.
61025-3
In Commercial Distribution

  • B29861025310 ()
61025-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MTD-OPI300-OXY-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60961-2
Not in Commercial Distribution

  • B2986096120 ()
60961-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI-PCP-THC-pH,SG.OX
Express Diagnostic Int'l, Inc.
60748-3
In Commercial Distribution

  • B29860748310 ()
60748-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BARB-BZO-COC-MTD-OPI-THC-pH,SG.OX
Express Diagnostic Int'l, Inc.
60712-3
In Commercial Distribution

  • B29860712310 ()
60712-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THL 4343 CsI Digital Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN260
In Commercial Distribution

  • 00817100020261 ()


  • Diagnostic x-ray digital imaging conversion system
3 panel test cup, COC/OPI2000/THC
AMEDITECH INC.
IMC-3P
Not in Commercial Distribution

  • 00816565020120 ()
IMC-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAV-10115
In Commercial Distribution

  • 20816490024006 ()
  • 10816490024009 ()
  • 00816490024002 ()
HCDOAV-10115

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAV-334
In Commercial Distribution

  • 20816490023856 ()
  • 10816490023859 ()
  • 00816490023852 ()
HCDOAV-334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
GBDOAEW-6125
In Commercial Distribution

  • 20816490022750 ()
  • 10816490022753 ()
  • 00816490022756 ()
GBDOAEW-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-254
In Commercial Distribution

  • 20816490021951 ()
  • 10816490021954 ()
  • 00816490021957 ()
HCDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup ;
Healgen Scientific Limited Liability Company
HCDOA-154
In Commercial Distribution

  • 20816490021944 ()
  • 10816490021947 ()
  • 00816490021940 ()
HCDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-6125
In Commercial Distribution

  • 20816490021821 ()
  • 10816490021824 ()
  • 00816490021827 ()
HCDOAF-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-8104
In Commercial Distribution

  • 20816490021210 ()
  • 10816490021213 ()
  • 00816490021216 ()
HCDOAF-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-1104S
In Commercial Distribution

  • 20816490021197 ()
  • 10816490021190 ()
  • 00816490021193 ()
HCDOA-1104S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-855
In Commercial Distribution

  • 20816490021142 ()
  • 10816490021145 ()
  • 00816490021148 ()
HCDOA-855

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-2104
In Commercial Distribution

  • 20816490020701 ()
  • 10816490020704 ()
  • 00816490020707 ()
HCDOAF-2104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-254
In Commercial Distribution

  • 20816490022590 ()
  • 10816490022593 ()
  • 00816490022596 ()
HCDOAEW-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-9125
In Commercial Distribution

  • 20816490022583 ()
  • 10816490022586 ()
  • 00816490022589 ()
HCDOAEW-9125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-6125
In Commercial Distribution

  • 20816490022279 ()
  • 10816490022272 ()
  • 00816490022275 ()
HCDOAEW-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Flat Cup
Healgen Scientific Limited Liability Company
HCDOAF-6124
In Commercial Distribution

  • 20816490022118 ()
  • 10816490022104 ()
  • 00816490022107 ()
HCDOAF-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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